Clinical Policy: Netarsudil (Rhopressa) Reference Number: ERX.NPA.68 Effective Date: 02.13.18 Last Review Date: 05.18 Revision Log

See Important Reminder at the end of this policy for important regulatory and legal information.

Description Netarsudil (Rhopressa®) is a .

FDA Approved Indication(s) Rhopressa is indicated for the reduction of elevated in patients with open-angle or .

Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.

It is the policy of health plans affiliated with Envolve Pharmacy Solutions™ that Rhopressa is medically necessary when the following criteria are met:

I. Initial Approval Criteria A. Open-Angle Glaucoma (must meet all): 1. Diagnosis of open-angle glaucoma or ocular hypertension; 2. Age ≥ 18 years; 3. Failure of two different classes of generic ophthalmic agents from the following, at up to maximally indicated doses unless contraindicated or clinically significant adverse effects are experienced: analog (e.g., ), ophthalmic beta-blocker (e.g., ), ophthalmic alpha-2 adrenergic agonist (e.g., ), parasympathomimetic (e.g., ), or carbonic anhydrase inhibitor (e.g., ); 4. Dose does not exceed 1 drop/eye/day (2 bottles or 5 mL/30 days). Approval duration: Length of Benefit

B. Other diagnoses/indications 1. Refer to ERX.PA.01 if diagnosis is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized).

II. Continued Therapy A. Open-Angle Glaucoma (must meet all): 1. Currently receiving medication via a health plan affiliated with Envolve Pharmacy Solutions or member has previously met initial approval criteria; 2. Member is responding positively to therapy; 3. If request is for a dose increase, new dose does not exceed 1 drop/eye/day (2 bottles or 5 mL/30 days). Approval duration: Length of Benefit

B. Other diagnoses/indications (must meet 1 or 2): 1. Currently receiving medication via a health plan affiliated with Envolve Pharmacy Solutions and documentation supports positive response to therapy. Approval duration: Duration of request or 12 months (whichever is less); or 2. Refer to ERX.PA.01 if diagnosis is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized).

III. Diagnoses/Indications for which coverage is NOT authorized:

Page 1 of 3 CLINICAL POLICY Netarsudil

A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off-label use policy – ERX.PA.01 or evidence of coverage documents.

IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration

Appendix B: Therapeutic Alternatives This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent and may require prior authorization. Drug Name Dosing Regimen Dose Limit/ Maximum Dose latanoprost (Xalatan®) 1 drop in the affected eye(s) once daily in the 1 drop/eye/day evening timolol (Timoptic®) 1 drop in the affected eye(s) twice daily 2 drops/eye/day brimonidine (Alphagan® P) 1 drop in the affected eye(s) three times daily 3 drops/eye/day pilocarpine 1 drop into the eye (s) up to four times a day 4 drops/eye/day (Isoto Carpine®) dorzolamide (Trusopt®) 1 drop in the affected eye(s) three times daily 3 drops/eye/day Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic.

V. Dosage and Administration Indication Dosing Regimen Maximum Dose Open-angle 1 drop into the affected eye(s) once daily in the 1 drop/eye/day glaucoma evening

VI. Product Availability Ophthalmic solution: 0.02% (0.2 mg/mL) in a 2.5 mL total volume per bottle

VII. References 1. Rhopressa Prescribing Information. Irvine, CA: Aerie Pharmaceutical, Inc.; December 2018. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208254lbl.pdf. Accessed January 8, 2018. 2. Prum BE, Lim MC, Mansberger SL et al. Primary Open-Angle Glaucoma Suspect Preferred Practice Pattern® Guidelines. Ophthalmology. 2016 Jan;123(1):P112-51. doi: 10.1016/j.ophtha.2015.10.055. 3. Serle JB, Katz LJ, Mclaurin E et al. Two Phase 3 clinical trials comparing the safety and efficacy of netarsudil to timolol in patients with elevated intraocular pressure. Am J Ophthalmol. 2017 Nov 30. pii: S0002-9394(17)30513-5. doi: 10.1016/j.ajo.2017. 4. Barcharach J, Dbiner HB, Levy B et al. Double-masked, randomized, dose-response study of AR- 133324 versus latanoprost in patients with elevated intraocular pressure. Am J Ophthalmol. 2015 Feb. 122(2)302-307. doi:10.1016/j.ophtha.2014.08.022.

Reviews, Revisions, and Approvals Date P&T Approval Date Policy created. 02.13.18 05.18

Important Reminder This clinical policy has been developed by appropriately experienced and licensed health care professionals based on a review and consideration of currently available generally accepted standards of medical practice; peer-reviewed medical literature; government agency/program approval status; evidence-based guidelines and positions of leading national health professional organizations; views of physicians practicing in relevant clinical areas affected by this clinical policy; and other available clinical information.

Page 2 of 3 CLINICAL POLICY Netarsudil

This Clinical Policy is not intended to dictate to providers how to practice medicine, nor does it constitute a contract or guarantee regarding payment or results. Providers are expected to exercise professional medical judgment in providing the most appropriate care, and are solely responsible for the medical advice and treatment of members.

This policy is the property of Envolve Pharmacy Solutions. Unauthorized copying, use, and distribution of this Policy or any information contained herein is strictly prohibited. By accessing this policy, you agree to be bound by the foregoing terms and conditions, in addition to the Site Use Agreement for Health Plans associated with Envolve Pharmacy Solutions.

©2018 Envolve Pharmacy Solutions. All rights reserved. All materials are exclusively owned by Envolve Pharmacy Solutions and are protected by United States copyright law and international copyright law. No part of this publication may be reproduced, copied, modified, distributed, displayed, stored in a retrieval system, transmitted in any form or by any means, or otherwise published without the prior written permission of Envolve Pharmacy Solutions. You may not alter or remove any trademark, copyright or other notice contained herein.

Page 3 of 3